Drug Product Recalls In 2010: Categorized By Problem Area

The information on drug product recalls in the following pages has been collected and categorized by “The Gold Sheet” from FDA “Enforcement Reports” issued during calendar year 2010. FDA’s weekly reports list recalls along with agency enforcement actions, such as seizures and injunctions. There is often a delay of several weeks or months between the issuing of a recall by a company and its appearance on the FDA list. Therefore, some recalls begun in 2009 may not appear until 2010. FDA indicates in the report whether the recalled products are regulated by the agency as drugs, biologics, medical devices/diagnostics, foods, or veterinary products. The list below includes only those recalls involving drug products and products making drug claims. Food supplements and biologic products, for example, have not been included. The list below has been divided into seven categories according to the reason for the recall cited by FDA. The general categories used below are: potency/content uniformity; dissolution; other product specifications; contamination/sterility assurance problems; labeling/packaging mix-ups; compliance with NDA/monograph requirements; and manufacturing/testing methods. In each category, recalls are listed by class, and alphabetically by company for each class. FDA designates a recall as falling into one of three classes according to the health threat posed by the product problem: Class I – violative product poses reasonable probability of serious adverse health consequences or death; Class II – violative product may cause temporary or medically reversible adverse health consequences, probability of serious consequences remote; Class III – violative product not likely to cause adverse health consequences.
Product	Mfr./Recaller	Class	Reason
Potency/Content Uniformity
Ranitidine Tablets	Amneal Pharmaceuticals.	II	Superpotent (single ingredient) drug. This product is being recalled because of two reports of oversized Ranitidine Tablets. Analysis of a tablet showed 149% of label claim.
Fluconazole	Hikma Farmaceutica/West-ward Pharmaceutical Corp.	II	Product Lacks Stability: Assay results for Fluconazole Injection 200 mg/100mL, lot number 092112.1 had out of specification assay results, both high and low, at 3 month stability testing.
Citalopram tablets USP	InvaGen Pharmaceuticals Inc.	II	Superpotent (Single Ingredient Drug); oversized tablets found.
Metoprolol tartrate tablets	Ipca Laboratories	II	Tablet thickness: Metoprolol tablets may be out of specification for tablet thickness.
Altace (ramipril) capsules	King Pharmaceuticals	II	Subpotent (Single Ingredient Drug): This product is being recalled because stability samples found that it was subpotent at the 6-month time point.
Allergy Relief (Diphenhydramine HCl) Capsules	Kirk Pharmaceuticals	II	Temperature abuse. Kirk Pharmaceuticals is recalling Diphenhydramine Hydrochloride 25mg capsules, for sub-potent assay results due to improper storage conditions of the product during transit.
Allergy Relief (Diphenhydramine HCl) Capsules	Kirk Pharmaceuticals, LLC	II	Temperature Abuse: Kirk Pharmaceuticals is recalling Diphenhydramine Hydrochloride 25mg capsules, for sub-potent assay results due to improper storage conditions of the product during transit.
Buphenyl (sodium phenylbutyrate) powder	Lyne Laboratories Inc./Medicis Pharmaceutical Corp.	II	Subpotent. The recall was initiated after recent tests showed that bottles from three lots could present a 3% to 9% under dosing to the patient.
Liothyronine sodium tablets	Metrics Inc./Paddock Laboratories Inc.	II	The recall is being conducted due to a stability failure at the 12 month timepoint; the assay value of this lot was found to be sub-potent.
Three products*	Novopharm Limited / Teva Pharmaceuticals USA, Inc.	II	Subpotent (single ingredient) drug. Some bottles may not meet fill weight specifications.
*Amoxicillin for oral suspension USP; Amoxicillin and clavulanate potassium for oral suspension USP; Penicillin V potassium for oral suspension USP
Amoxicillin for oral suspension in 80 ml, 100 ml and 150 ml bottles	Novopharm Ltd./Teva Pharmaceuticals USA, Inc.	II	Superpotent (single ingredient drug). Samples had 116.7g and 118.8g which resulted in an excess dosage 218% of label claim and 222% of label claim.
Diflorasone Diacetate Cream	Nycomed U.S., Inc.	II	Superpotent (Single Ingredient) Drug: Out-of-specification (OOS) assay results both above and below the approved specification (90-110%) were found in the recalled lots.
Medrol methylprednisolone tablets USP	Pfizer Italia S.r.L./Pharmacia and Upjohn Co.	II	Subpotent (single ingredient drug). The firm voluntarily initiated this recall when it was determined that this lot did not meet assay specifications on stability.
Prednisone tablets USP	Qualitest Pharmaceuticals /Vintage Pharmaceuticals LLC	II	Superpotent (single ingredient drug). A tablet was found to be 129.5% of the label claim.
Tamoxifen citrate tablets USP	Teva Pharmaceutical Industries Ltd./Teva Pharmaceuticals USA Inc.	II	Tablet thickness. Some tablets may not meet weight requirements.
Cephalexin for oral suspension	Teva Pharmaceuticals USA Inc.	II	Subpotent (single ingredient) drug. The product was found to be subpotent at the 12 month stability time point.
Glyburide and Metformin HCl	USV Limited/Dr Reddy’s Laboratories Inc.	II	Adulterated presence of foreign tablets. One batch of Glyburide and Metformin Hydrochloride Tablets 2.5 mg/500 mg may have Glyburide Metformin Hydrochloride 5 mg/500 mg tablets co-mingled in it.
Spironolactone tablets, USP 25 mg	Vintage Pharmaceuticals	II	Subpotent (Single Ingredient Drug): out of specification (OOS) stability results for assay 94.2% (specification 95.0-105.0%) at the 6-month time point.
Spironolactone Tablets	Vintage Pharmaceuticals LLC	II	Subpotent (single ingredient drug). Out of specification (OOS) stability results for assay 94.2% (specification 95.0-105.0%) at the 6-month time point.
Ibudone hydrocodone bitartrate and ibuprofen tablets	Vintage Pharmaceuticals LLC	II	Subpotent (multiple ingredient drug). Below specification for the assay at the room temperature 3-month stability time-point for Ibuprofen and Hydrocodone Bitartrate.
Digoxin tablets, USP, 125 mcg	West-ward Pharmaceutical Corp.	II	Superpotent (Single Ingredient Drug): West-Ward received a complaint from a pharmacist stating that some tablets of Digoxin in a bottle of 1,000 tablets were thicker than others.
Clear Nicotine (nicotine) transdermal system patch, 7 mg, 14 mg and 21 mg strengths	AVEVA Drug Delivery Systems Inc.	III	Product could be subpotent or have myosmine and beta-nicotyrine impurities above the 0.50% specification limit.
Terazosin HCl Capsules	Cadista Pharmaceuticals, Inc.	III	Pharmaceutical may have been packaged with two dosage strengths of the same drug.
Coats Aloe Vera Liniment (Methyl Salicylate) 10%; The Silent Healer by Coats Aloe Liniment Topical Analgesic, (methyl salicylate) 10%; R Pur Aloe International (methyl salicylate) Whole Leaf Aloe Vera Liniment, 10%	Coats International Holdings, Inc.	III	Sample product failed 6-month ambient test points for assay of active ingredient.
Formo Cresol Solution; Dry Socket Remedy	Dentsply Caulk/DSHealthcare Inc.	III	Subpotent: During 12-month stability testing point the products failed to meet their specifications for active ingredients.
Four products containing salts of amphetamine and dextroamphetamine, including Adderall XR	DSM Pharmaceuticals Inc./Shire Pharmaceuticals Inc.	III	Subpotency (under-filled capsules).
Four menthol cough drop products*	F & F Foods Inc.	III	Subpotent (single ingredient drug). Cough drops are out of specification for menthol.
*Honey Lemon Soothing Cough Drops; Menthol Eucalyptus Soothing Cough Drops; Therastat Cough Lozenges; Thoracol Cough Lozenges
Benziq Wash (benzoyl peroxide 5.25%) gel	Harmony Labs Inc./Graceway Pharmaceuticals LLC	III	Subpotent (single ingredient drug). Below specification for Benzoyl Peroxide at the 20 month stability testing interval.
Derma-Smoothe/FS (fluocinotone acetonide) 0.01% topical oil (scalp oil)	Hill Dermaceuticals Inc.	III	Subpotent; 23 month stability.
Tri-Luma (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) Cream	Hill Dermaceuticals Inc./Galderma Laboratories	III	Subpotent (multiple ingredient drug). Firm was notified by supplier of a subpotent active ingredient.
DermOtic Oil (fluocinolone acetonide) 0.01% ear drops	Hill Dermaceuticals, Inc.	III	Subpotent prior to the expiration date.
Shopko Cold/Flu Relief Multi-Symptom Day Time	IGA Inc.	III	Sub-potent; dextromethorphan Hbr.
ShopKo Cold/Flu Relief Multi Symptom Night Time Original (acetaminophen 500 mg, dextromethorphan HBr 15 mg and doxylamine succinate 6.25 mg per 15 ml tablespoon) liquid	IGI Inc.	III	Superpotency for doxylamine succinate during stability testing.
Triamcinolone acetonide injectable suspension, USP, 50 mg/5 ml and 40 mg/ml	Sandoz Canada Inc./Sandoz Inc.	III	Failed USP content uniformity requirements. Drug was out of specification for redispersibility at the 12 month time point.
Antibacterial Washcloths (Benzalkonium chloride)	Soshio Wet Tissue Co., Ltd./Rockline Industries	III	Subpotent (single ingredient) drug: It is subpotent and does not have an expiration date.
Dissolution
PhosLo (calcium acetate) gelcaps	Braintree Laboratories Inc./Fresenius Medical Care Holdings Inc.	II	Failed USP Dissolution Test Requirements: fails dissolution and may result in hyperphosphatemia.
Isosorbide dinitrate extended release tablets	Corepharma LLC	II	Failed USP Dissolution Test Requirements: Out of Specification results for dissolution at the 9 month time test interval.
Dipyridamole Tablets	Lannett Co.	II	Failed USP dissolution test requirements.
Motrin IB (Ibuprofen) caplets USP	McNeil Healthcare	II	Failed Dissolution Specification.
Demser (Metyrosine) capsules	Merck/Aton Pharma, Inc.	II	Failed USP dissolution test requirements. Samples have failed to meet dissolution specifications.
Compro Prochlorperazine Suppositories	Paddock Laboratories, Inc.	II	Failing dissolution results at the 6-month stability time point.
Chlor-Trimeton 12-hour chlorpheniramine maleate	Schering Canada Inc./Schering-Plough	II	Above specification results in dissolution testing.
Sulfamethoxazole and trimethoprim oral suspension, USP	Vintage Pharmaceuticals LLC	II	Failed USP dissolution test requirements. Out of specification at 3-month stability time point for dissolution.
Six Embeda (morphine sulfate and naltrexone HCl) extended release tablets 20 mg/0.8 mg, 30 mg/1.2 mg, 60 mg/2.4 mg, 50 mg, 2.0 mg, 80 mg, 3.2 mg and 100 mg/4 mg	Actavis Elizabeth LLC /King Pharmaceuticals Inc.	III	Failed dissolution testing for Morphine Sulfate during stability testing.
Embeda (morphine sulfate and naltrexone HCl) extended release capsules	Actavis Elizabeth LLC/King Pharmaceuticals Inc.	III	Product does not meet sustained release specs. Two lots were found to be out of specification (dissolution testing) for Morphine Sulfate.
Diphenhydramine HCl USP softgels	Banner Pharmacaps Inc.	III	One lot of product is being recalled because of OOS dissolution results (73% at Stage 3, spec. NLT 80%) at the 12 month time point.
Claravis isotretinoin capsules USP	Barr Laboratories Inc./Teva Pharmaceuticals USA Inc.	III	Failed USP dissolution test requirements. 18 month stability testing revealed that the product may dissolve slower than intended.
Claravis (Isotretinoin)	Barr Laboratories Inc./Teva Pharmaceuticals USA, Inc.	III	Some capsules do not meet dissolution specifications.
Bayer aspirin enteric coated caplets, 81 mg and 325 mg strengths	Bayer Corp./Bayer Healthcare LLC	III	Failed USP dissolution test requirements. Out of specification dissolution.
Wellbutrin XL (Buproprion HCl extended release tablets)	Biovail Corp./BTA Pharmaceuticals Inc.	III	The dissolution release rate is below specification for two tablets at the four hour time point.
Potassium citrate extended-release tablets USP	Corepharma LLC	III	Failed USP dissolution test requirements. Out of Specification value for dissolution at the 3 month stability test interval.
UROCIT-K (potassium citrate) extended-release tablets	Mission Pharmacal Co.	III	The firm initiated this recall due to OOS dissolution results found during stability testing. The product was found to release the active ingredient slower than the specification requirement.
Zmax (Azithromycin) Extended Release For Oral Suspension	Pfizer Inc.	III	Failed USP dissolution test requirements. Zmax is being recalled because it was determined that certain lots did not meet dissolution specifications on stability.
Isosorbide mononitrate tablets	West-ward Pharmaceutical Corp./Promius Pharma, LLC	III	Failed Dissolution Specification; 44 month time point.
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets)	Wyeth Pharmaceuticals	III	These lots do not conform to the dissolution specifications for conjugated estrogens as specified in the firm's New Drug Application (NDA) for Prempro.
Other Product Specification
Symbicort (budenoside 160 mcg and formoterol fumarate dihydrate 4.5 mcg) inhalation aerosol	A.S.P. S.A./AstraZeneca	II	Miscalibrated and/or defective delivery system. The counter dials on the Symbicort inhalers were confirmed to be undercounting during actuation however, the units are delivering the product as designed.
Triple antibiotic (Polymyxin B Sulfates, Bacitracin Zinc, Neomycin, Pramoxine HCl) ointment	Actavis Mid Atlantic	II	Degradation failure: 6 month stability time point.
Claritin Eye (Ketotifen Fumarate) Ophthalmic Solution	Apotex Corp.	II	Failed pH specifications.
Carbamazepine tablets USP	Apotex Corp.	II	Product was manufactured with an API batch that was Out Of Specification (OOS) for an unknown impurity.
Zolpidem tartrate tablets	Aurobindo Pharma Limited	II	Tablet Thickness: One oversize tablet was found in two lots of Zolpidem Tartrate Tablets, 10 mg, 500 count.
Children's Nasal Decongestant Liquid (Pseudoephedrine HCl)	Bio-Pharm, Inc./Rugby Laboratories, Inc.	II	Miscalibrated and/or defective delivery system. The dosage cup provided with the product is not consistent with the dosing instructions.
Nifediac CC (Nifedipine) extended-release tablets	Biovail Corp./Biovail Pharmaceuticals	II	Product does not meet sustained release specifications. Active ingredient may release slightly faster than required by product release rate specification.
Ultram ER (tramadol HCl) extended-release tablets	Biovail Corp./Ortho-McNeil Pharmaceutical, Inc.	II	Product does not meet sustained release specifications. Certain lot numbers may release the active ingredient at a slightly faster rate than required by the products release specification at the 8 hour and 10 hour time points.
Coumadin warfarin sodium tablets USP	Bristol Myers Squibb Holdings Pharma Ltd./Bristol Myers Squibb	II	The recall is based upon the firm's determination that some tablets may not meet specification for isopropanol, which is required to maintain the active ingredient in a crystalline state. The firm's medical assessment indicates that the use of tablets with low isopropanol could, in some cases, potentially lead to patient-to-patient variation in bioavailability.
Prednisone Tablets	Cadista Pharmaceuticals, Inc.	II	Pharmaceutical failed to meet specification at 18 month stability station.
Methimazole USP 5 mg and 10 mg tablets	Caraco Pharmaceutical Laboratories	II	Impurities/Degradation products. The product failed 18 month stability testing.
Glycopyrrolate Tablets USP, 1 mg and 2 mg	Corepharma LLC	II	Impurities/Degradation Products: An investigation had determined that some lots of Glycopyrrolate 1 mg and 2 mg Tablets have the potential to exceed specifications for Impurity-I content over the shelf life of the product.
Pilocarpine Hydrochloride Tablets	Corepharma LLC	II	One lot of Pilocarpine Hydrochloride Tablets, 5 mg may contain out of specification tablets for weight and thickness.
Zinotic ES (chloroxylenol, pramoxine HCl and zinc acetate dihydrate otic solution)	Gorbec Pharmaceutical Services Inc./Arbor Pharmaceuticals Inc.	II	Impurities/degradation products. The affected batches, during stability testing, yielded results higher than acceptable levels of impurities.
Lorazepam injection, USP	Hospira / AmeriSource Bergen	II	Temperature Deviation; product had not been stored according to manufacturer's labeled temperature requirements prior to distribution.
Sterile Visine All Day Eye Itch Relief (Ketotifen Fumarate) Opthalmic Solution Antihistamine Eye Drops	Johnson & Johnson Consumer Group of Companies, Inc.	II	Failed PH Specifications: out of specification (OOS) results for pH (results 4.229, limit is from 4.4 to 5.8) at the 6-month stability testing.
OctreoScan Kit for the Preparation of Indium In-111 Pentetreotide, 10 mL Reaction Vial containing 10 mcg lyophilized Pentetreotide	Mallinckrodt Inc.	II	Lack of Efficacy: The product is not performing within acceptable production specifications (radiochemical purity).
Zyrtec Itchy Eye Drops (ketotifen fumarate)	McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.	II	Failed pH Specifications: out of specification (OOS) results for pH during stability testing.
Amlodipine Besylate and Benazepril HCl Capsules	Novartis Pharmaceuticals Corp.	II	During sample preparation of Amlodipine Besylate & Benazepril HCl 5 mg/10 mg combination product at the 6 month stability interval, one capsule of lot F1031 did not contain the Benazepril 10 mg tablet.
Daytrana (methylphenidate transdermal system)	Noven Pharmaceuticals Inc./Shire Pharmaceuticals Inc.	II	Miscalibrated and/or Defective Delivery System: The lot being recalled was found to be out of specification for mechanical peel force of the adhesive liner during stability testing, which could cause patients or caregivers to have difficulty removing the liner.
Daytrana (Methylphenidate Transdermal System) 20 mg and 30 mg	Noven Pharmaceuticals, Inc./Shire PLC	II	Miscalibrated and/or defective delivery system. No longer meets the release liner removal specification.
Four products*	Noven Pharmaceuticals, Inc./Shire PLC	II	Miscalibrated and/or Defective Delivery System no longer meets the release liner removal specification.
* Daytrana (Methylphenidate Transdermal System) 10, 15, 20 and 30 mg
Vick’s Sinex (Phenylephrine HCl 0.5%) nasal spray	Olay LLC / Procter & Gamble Co.	II	Stability data does not support expiration date/presence of precipitate. The product formulation may not meet the expiration dates on the package and found evidence of a chlorhexidine precipitate.
Aceon (perindopril erbumine) tablets	Patheon Pharmaceuticals Inc./Abbott Products Inc.	II	Impurities/Degradation Products: A known degradation (RWJ-4191) was found to be above specification at the 16 month/25 degrees C/60% RH stability interval.
Arthrotec 50 & Arthrotec 75 (diclofenac sodium/misoprostol)	Pfizer US Pharmaceutical Group	II	Tablet separation: The product may contain broken tablets.
Dronabinol 2.5 mg USP gelatin capsules	Pharmaceutics International Inc./American Health Packaging	II	Temperature abuse. The affected product was stored below freezing conditions for 10-12 hrs. Liquid filled gelatin capsules that are subjected to conditions below freezing have an increased possibility of leaking due to the gelatin becoming brittle or the volume of the liquid inside shrinking and expanding.
Kit for the preparation of Technetium Tc99m Pentetate injection (DTPA)	Pharmalucence Inc.	II	Product lacks stability. Technetium Tc99m Pentetate Injection does not maintain 90% Radiochemical Purity (RCP) for up to six hours after reconstitution with up to 160 mCi of Technetium Tc99m.
Pulmolite kit for preparing Technetium Tc99m albumin aggregated injection)	Pharmalucence Inc.	II	Product Lacks Stability: Product does not meet stability to expiration date and exhibits low particle counts which could lead to a non-diagnostic scan.
Ketotifen Ophthalmic Solution Eye Drops	PL Developments, Inc.	II	Failed pH specifications: out of specification (OOS) results for pH during stability testing.
Amoxicillin and Clavulanate Potassium for Oral Suspension	Ranbaxy Pharmaceuticals, Inc.	II	Complaints received of 2 lots of Amoxicillin & Clavulanate Potassium for Oral Suspension turning brown upon reconstitution. The product should be white.
Glycopyrrolate tablets	Rising Pharmaceuticals, Inc./American Health Packaging	II	Impurities/Degradation Products: Some lots of Glycopyrrolate 2 mg tablets have the potential to exceed specifications for Impurity-I content over the shelf life of the product.
Intron A (Interferon alfa-2b, recombinant) Solution for Injection in 3 MIU, 5 MIU and 10 MIU Multidose pens	Schering-Plough (Brinny) Co./Schering Corp.	II	Impurities/degradation products. Stability failure at 18 months detected impurities in Intron A (interferon alfa-2b, recombinant) Solution in Multidose Pen for Injections.
Isosorbide mononitrate extended-release tablets	Schwarz Pharma Manufacturing Inc.	II	Tablet Thickness; presence of thicker, overweight tablets due to presence of start-up waste in acceptable product.
Adagen (pegademase bovine) injection	Sigma-tau Pharmasource Inc.	II	Impurities/degradation products found during routine stability testing. The impurity level was 2.1%, which is above the specification level of 2%.
Haloperidol Decanoate IM injection, single vials and packages of 10 vials	Teva Parenteral Medicines Inc./Teva Pharmaceuticals USA, Inc.	II	Impurities/Degradation Products: Product does not meet impurity specifications.
Dacarbazine for injection USP	Teva Parenteral Medicines Inc./Teva Pharmaceuticals USA, Inc.	II	Product may exhibit discoloration.
Multitrace-5 Concentrate	Luitpold Pharmaceuticals, Inc.	III	Out-of-specification product for aluminum levels.
An OTC inhalable: S-2 2.25% Racepinephrine 30 x 0.5ml sterile inhalation, OTC	Gilead Sciences Inc./Cardinal Health Care	III	Temperature abuse. Product stability may have been compromised due to defective refrigeration storage unit.
Two OTC oral liquids*	Gilead Sciences Inc./Cardinal Health Care	III	Temperature abuse. Product stability may have been compromised due to defective refrigeration storage unit.
* Lactinex (lactobacillus) (granules/dietary supplement), 12x1gm, OTC, Becton Dickinson microbiology system; Lactinex 50, (lactobacillus), OTC, Becton Dickinson microbiology system
Four Rx inhalables*	Gilead Sciences Inc./Cardinal Health Care	III	Temperature abuse. Product stability may have been compromised due to defective refrigeration storage unit.
*Amyl nitrite inhalant, USP, 12 0.3ml ampule; Foradil aerolizer (formoterol fumarate inhalation powder), 12mcg 12 capsules with device; Foradil aerolizer (formoterol fumarate inhalation powder), 12mcg 60 capsules with device; Pulmozyme inhalation solution, (dornase alfa), 1mg/ml, as 30 x 2.5ml ampules
146 injectables*	Gilead Sciences Inc./Cardinal Health Care	III	Temperature abuse. Product stability may have been compromised due to defective refrigeration storage unit.
* Alprostadil (prostaglandin E1), 500mcg/ml 5 x 1ml; Ambisome injection (amphotericin B) liposome for injection, 50mg; Amphadase injection (hyaluronidase injection, USP) not for IV use, 150 u/ml, 10x1 ml pfl; Amphadase injection, (hyaluronidase injection, USP), not for IV use, 150 u/ml 25 x 1 ml pfl; Amphotericin b for injection, 50mg 1 vial, Rx only; Amphotericin b for injection 50mg 1 vial; Apidra injectable [insulin glulisine (rDNA origin) injection], 100u/ml 10ml; Apidra injectable [insulin glulisine (rDNA origin) injection], 100u/ml 5x3ml, for use only in opticlik insulin delivery device; Aquasol a parenteral water-miscible, Vitamin A Palmitate, solution 50mu/ml 10x2ml; Avonex, 30mcg 4 prefilled syringe; Baciim (bacitracin for injection USP), powder for inj., solution 50mu 10 vials, for intramuscular use; Baciim (bacitracin for injection USP) powder for inj., solution 50mu 10vial; Bacitracin for injection 50mu 1vial; Bacitracin for inj. 50mu 1vial; Bleomycin for injection, ups, equivalent to 15 units bleomycin, single use 1vial for IV, IM, SC or intrapleural use; Bleomycin for injection 15u 1vial; Bleomycin for injection 30u 1vial; Cancidas (caspofungin acetate) for injection 50mg 1vial; Cancidas (caspofungin acetate) powder for injection, 70mg 1vial; Caverject, 40mcg 6 vial; Cenolate inj. 500mg/ml (ascorbic acid injection, USP), single dose, 50x1ml; Cenolate inj. 500mg/ml 50x2ml, (ascorbic acid injection, USP), single dose; Cerebyx inj. (fosphenytoin sodium injection), 50mg/ml 10x10ml; Cerebyx inj. (fosphenytoin sodium injection), 50mg/ml 25x2ml; Cladribine injection, 1mg/ml 10ml, single dose vial, for intravenous infusion; Cleviprex (clevidipine butyurate injectable emulsion), 0.5mg/ml, 10x100ml; Curosurf (poractant alfa) intratracheal suspension, 80mg/ml 1.5ml single use vial; Curosurf (poractant alfa) intratracheal suspension, 80mg/ml 3ml single use vial; Desmopressin acetate inj. 4mcg/ml 10x1ml; Desmopressin acetate 4mcg/ml 10ml; Desmopressin acetate 4mcg/ml 10 x 1ml; Diltiazem HCl injection, 5mg/ml 10x10ml, single-dose fliptop vial, for direct IV bolus injection and continuous IV infusion; Diltiazem HCl injection, 5mg/ml 10x5ml, single-dose fliptop vial, for direct IV bolus injection and continuous IV infusion; Doxil, (doxorubicin HCl liposome injection), inj. 2mg/ml 10ml,sterile, single use vial, for intravenous infusion only; Doxil (doxorubicin HCl liposome injection), inj. 2mg/ml 25ml, sterile, single use vial, for intravenous infusion only; Eligard (leuprolide acetate for injectable suspension), 22.5mg for inj. suspension, sterile, for subcutaneous injection, Rx only; Eligard (leuprolide acetate for injectable suspension), 45mg; Eligard (leuprolide acetate for injectable suspension), 7.5mg; Eligard (leuprolide acetate for injectable suspension), 30mg, sterile; Emend (fosaprepitant dimeglumine) for injection, 115mg 1vial; Epirubicin HCl inj., 2mg/ml 100ml, for IV use only, cytotoxic agent; Fludarabine phosphate for injection, 25mg/ml 2ml, single dose vial for IV use only; Fludarabine phosphate for injection 50mg 1vial, single dose vial for IV use only; Forteo (teriparatide [rDNA origin]) injection, 250mcg/ml 3ml, for subcutaneous use; Fosphenytoin sodium injection USP, 50mg/ml 10x10ml single dose vials; Fosphenytoin sodium injection USP, 50mg/ml 10x10ml single dose vials; Fosphenytoin sodium injection USP, for IM or IV use; Fosphenytoin sodium injection, for IM or IV use; Fosphenytoin sodium injection, USP, 50mg/ml 10x10ml single dose vials; Fosphenytoin sodium injection, USP, 50mg/ml 25x2ml single dose vials; Fosphenytoin sodium 50mg/ml 10 x 10ml, Rx only; Fosphenytoin sodium 50mg/ml 25 x 2ml; Fosphenytoin sodium, 50mg/ml 10 x 10ml; Humatrope cartridge kit, (somatropin [rDNA origin]) for injection, 12mg ; Humatrope for inj. (somatropin [rDNA origin]) for injection, 5mg ; Humatrope cartridge kit (somatropin [rDNA origin]) for injection, 6mg ; Idarubicin HCl injection, 1mg/ml 5ml, single dose vial; Idarubicin HCl inj. 1mgml 20ml, single dose vial; M.V.I. adult (multi-vitamin infusion), for dilution in intravenous infusions only, 10ml/2vialx10 units ; M.V.I. adult (multi-vitamin infusion), for dilution in intravenous infusions 10x10ml units ; M.V.I. pediatric (multi-vitamin infusion), for reconstitution and dilution in intravenous infusions only, ten 5ml single dose vials, sterile; M.V.I.-12 (multi-vitamin infusion without Vitamin K) unit vial, for dilution in intravenous infusions only, 10 unit vials of 10ml each to be used as a single dose; M.V.I.-12 (multi-vitamin infusion without Vitamin K) 50ml/2vialx10; Norditropin cartridge somatropin (rDNA origin) injection, 15mg/1.5ml; Norditropin cartridge somatropin (rDNA origin) injection, 5mg/1.5ml; Norditropin nordiflex (somatropin [rDNA origin]) injection 10mg/1.5ml; Norditropin nordiflex (somatropin [rDNA origin]) injection 5mg/1.5ml prefilled pen; Octreotide acetate injection, 0.5mg/ml 10x1ml, single dose vials; Octreotide acetate injection, 0.2mg/ml 5ml, single dose vials; Octreotide acetate injection, 0.1mg/ml 10x1ml single dose vials; Octreotide acetate injection, 1mg/ml, 5ml multiple dose vial; Omnitrope (somatropin [rDNA origin] for injection) and diluent with preservation (bacteriostatic water for injection 1.14ml) 5.8mg; Omnitrope (somatropin [rDNA origin] infection, 5mg/1.5ml cartridge; Ovidrel (choriogonadotropin alfa injection) prefilled syringe, 250mcg, 0.5ml; Survanta, (beractant) intratracheal suspension, sterile suspension for intratracheal administration only, not for injection, 25mg/ml 4ml single use vial; Survanta (beractant) intratracheal suspension, 25mg/ml 8ml, sterile suspension for intratracheal administration only, not for injection; Tetracaine HCl 1% (tetracaine HCl injection), USP, for prolonged spinal anesthesia, 25 x 2ml; Tev-tropin [somatropin (rDNA origin) for injection] 5mg 1vial with diluent, reconstitute with bacteriostatic 0.9% sodium chloride injection; Torisel kit, (temsirolimus), 25mg with diluent;
Vincasar pfs (vincristine sulfate injection, USP), 1mg/ml 1ml, single dose vial; Vincasar pfs (vincristine sulfate injection, USP), 2mg/2ml, single dose vial; Vinorelbine tartrate injection equivalent to vinorelbine, 10mg/ml 5ml single-use vial; Vinorelbine tartrate injection, equivalent to vinorelbine, for intravenous use only, 10mg/ml 5ml single-use vial; Vitrase (hyaluronidase injection) ovine kit, 200u/ml 6 single use vials x 1.2ml; Zanosar (streptozocin sterile powder) 1gm 1 single dose vial, for intravenous use only; Infasurf (calfactant), 35mg/ml 3ml suspension, single use vial; Infasurf (calfactant), 35mg/ml 6ml suspension, single use vial; Premarin intravenous (conjugated estrogens, USP) for injection, 25mg 1vial; Nimbex injection (cisatracurium besylate), 2mg/ml 10 x 5ml; Nimbex injection (cisatracurium besylate), 200mg 10mg/ml 20ml; Nimbex injection (cisatracurium besylate), 20mg 2mg/ml 10 x 10ml; Amevive IM kit, 15 mg, 4 vials of lyophilized powder for injection; Amevive IM kit 15 mg, 1 vial lyophilized powder for injection; Aranesp (darpepoetin alfa) recombinant, 150mcg/0.75ml, 4 x 0.75ml single use vials; Aranesp (darpepoetin alfa) recombinant, singleject 40mcg/0.4ml, 4 x 0.4 ml; Aranesp (darpepoetin alfa) recombinant, singleject 150mcg/0.3ml, 4 x 0.3ml; Aranesp (darpepoetin alfa) recombinant, singleject 60mcg/0.3ml, 4 x 0.3ml; Aranesp (darpepoetin alfa) recombinant, singleject 500mcg/1ml; Aranesp (darpepoetin alfa) recombinant, singleject 25mcg/0.4ml, 4 x 0.4ml; Aranesp (darpepoetin alfa) recombinant, singleject 200mcg/0.4ml; Aranesp,(darpepoetin alfa) recombinant, singleject 100mcg/0.5ml; Aranesp (darpepoetin alfa) recombinant, sureclick 40mcg/0.4ml; Aranesp (darpepoetin alfa) recombinant, sureclick 200mcg/0.4ml; Aranesp (darpepoetin alfa) recombinant, singleject 300mcg/0.6ml; Aranesp (darpepoetin alfa) recombinant, 200mcg/ml 1ml single use vials; Aranesp (darpepoetin alfa) recombinant, 25mcg/ml, 4 x 1ml single use vials; Aranesp (darpepoetin alfa) recombinant, 300mcg/ml, 1ml single use vials; Aranesp (darpepoetin alfa) recombinant, 40mcg/ml, 4 x 1ml single use vials; Aranesp (darpepoetin alfa) recombinant, 60mcg/ml, 4 x 1ml single use vials; Aranesp (darpepoetin alfa) recombinant, 100mcg/ml, 4 x 1ml single use vials; Avastin inj. (bevacizumab), 25mg/ml 16ml, list no. 16482, single use vial; Avastin inj. (bevacizumab), 25mg/ml 4ml, list no. 15734, single use vial; Avonex (interferon beta-la), 30mcg, 4 vial; Cathflo activase (alteplase), powder for inj. 2mg 1vial; Amgen Enbrel (etanercept), Sureclick 50mg/ml, 4 single-use prefilled Sureclick autoinjectors; Amgen Enbrel (etanercept), 25mg/4 multiple-use vial; Amgen Enbrel (etanercept), 25mg/0.5ml, 4 single-use prefilled syringes; Amgen Enbrel (etanercept), 4 x 50mg/ml single-use prefilled syringes; Amgen Epogen, (epoetin alfa, recombinant), 10mu/ml 10x2ml single use vials; Amgen Epogen (epoetin alfa, recombinant), 10mu/ml 10x1ml single use vials; Amgen Epogen (epoetin alfa, recombinant), 20mu/ml 10 x 1ml single use vials; Amgen Epogen (epoetin alfa, recombinant), 2mu/ml 10 x 1ml single use vials; Amgen Epogen (epoetin alfa, recombinant), 3mu/ml 10 x 1ml single use vials; Amgen Epogen (epoetin alfa, recombinant), 40mu/ml 10 x 1ml single use vials; Amgen Epogen (epoetin alfa, recombinant), 4mu/ml 10 x 1ml single use vials; Herceptin kit (trastizibab), 440mg multi-dose vial; Humira pen (adalimumab) 40mg/0.8ml 27g needle 2 single-use prefilled pens; Humira pen (adalimumab) 40mg/0.8ml 27g needle 6 single-use prefilled pens, crohn's disease starter package; Humira (adalimumab) syringe, 40mg/0.8ml 2 single-use prefilled syringes (2), 40mg/0.8ml; Infergen (interferon alfacon-1), a recombinant consensus alpha interferon, for subcutaneous use only, 15mcg/0.5ml 6x0.5ml, single-use vials; Infergen (interferon alfacon-1), a recombinant consensus alpha interferon, for subcutaneous use only, 9mcg/0.3ml 6x0.3ml, single-use vials; Intron a (interferon alfa-2b, recombinant) solution for injection 10mmu/0.2ml 1.5ml, multidose pen, for subcutaneous use; Intron a (interferon alfa-2b, recombinant) solution for injection, 25 million iu multidose vial, 5 million iu/0.5 ml, for intramuscular/subcutaneous use; Intron a (interferon alfa-2b, recombinant) solution for injection 6mmu/ml 3.8ml, multidose vial, for intramuscular/subcutaneous use; Interferon alfa-2b, recombinant 10mmu 1 vial with diluent; Kineret (anakinra), 100mg/0.67ml 28x0.67ml, single use prefilled glass syringes with 27 gauge needles; Amgen Neulasta (pegfilgrastim), pegylated recombinant methionyl human granulocyte colony stimulating factor (peg-r-methug-csf) derived from ecoli, 6mg/0.6ml 0.6ml, single use prefilled syringe; Procrit (epoetin alfa) sterile solution for injection, for intravenous or subcutaneous use only, 10mu/ml 25x1ml vials; Prostin vr pediatric (alprostadil injection, USP). 5x1ml ampoules; Reopro solution, (abciximab), 2mg/ml 5ml vial; Rituxan (rituximab) injection, 10mg/ml vial, 10ml vial; Vectibix (panitumumab), single use vial injection 20mg/ml 10ml; Vectibix (panitumumab), single use vial 20mg/ml 20ml; Vectibix (panitumumab), single use vial injection 20mg/ml 5ml; Xigris (drotrecogin alfa, activated), 1 x 5mg vial, for intravenous use; Xigris (drotrecogin alfa, activated), 1 x 20mg vial
Two nasal products*	Gilead Sciences Inc./Cardinal Health Care	III	Temperature abuse. Product stability may have been compromised due to defective refrigeration storage unit.
* Desmopressin acetate nasal solution 0.1mg/ml 5ml; DDAVP rhinal tube, (desmopressin acetate), for intranasal use only, 10mcg/0.1ml, 2.5ml
Three oral liquids*	Gilead Sciences Inc./Cardinal Health Care	III	Temperature abuse. Product stability may have been compromised due to defective refrigeration storage unit.
* Nystat-Rx, nystatin USP, 150 million units, 1gm bulk; Prednisolone sodium phosphate oral solution, 5mg/5ml, 120 ml bottle; Vfend (voriconazole) for oral suspension, orange flavored, 40mg/ml 75ml
Three ophthalmics*	Gilead Sciences Inc./Cardinal Health Care	III	Temperature abuse. Product stability may have been compromised due to defective refrigeration storage unit.
* Alcaine (proparacaine HCl USP) ophthalmic solution, 0.5%; Trifluridine ophthalmic solution, 1% 7.5ml sterile; Viroptic ophthalmic solution 1% (trifluuridine ophthalmic solution) sterile, 7.5ml drop dose
Six oral solids*	Gilead Sciences Inc./Cardinal Health Care	III	Temperature abuse. Product stability may have been compromised due to defective refrigeration storage unit.
* Aptivus (tipranovir) 250mg 120 softgel capsules; Emcyt capsules, (estramustine phosphate), 140mg 100; Leukeran (chlorambucil) tablets 2mg 50 tablets; Norvir (ritonavir capsules) 100mg, 30 soft gelatin capsules; Syprine (trientine HCl), 250mg capsule x 100 capsules; Norvir (ritonavir capsules) soft gelatin, 100mg 30 capsules
Six topicals*	Gilead Sciences Inc./Cardinal Health Care	III	Temperature abuse. Product stability may have been compromised due to defective refrigeration storage unit.
* Clorpactin WCS-90, 5x2gm, (brand of oxychlorosene, sodium); Neomycin and polymyxin B sulfates solution for irrigation, 10x1ml; Neomycin and polymyxin B sulfates solution for irrigation, USP (sterile); Neomycin and polymyxin B sulfate solution for irrigation, 10x1ml ampules; Neomycin/polymyxin B 50x1ml irrigation; Soluclenz Rx gel (benzoyl peroxide 5%), 27ml
Clindamycin Injection, USP, 300 mg/2ml, 600 mg/4ml, 900 mg/6 ml and 9 grams/60 ml	APP Pharmaceuticals	III	Impurities/Degradation Products: This product is being recalled because the lots have failed or have the potential to fail the Total Impurities specification before expiration.
Clear Nicotine (Nicotine) Transdermal System Patch	AVEVA Drug Delivery Systems, Inc.	III	Impurities/degradation products. Product tested out of specification for two degradants, myosmine and beta-nicotyrine.
Coats Aloe Natural Sun Protection (titanium Dioxide 6%/zinc oxide 2.2%) SPF 30+ Lotion -- tinted and untinted	Coats International Holdings, Inc.	III	Product was distributed without proper stability data to support the 2 year shelf-life.
Cortamox Lotion (hydrocortisone/pramoxine HCl/chloroxylenol)	Harmony Labs, Inc./River’s Edge Pharmaceuticals, LLC	III	Product lacks stability: Long term stability failure.
Selenium Sulfide Shampoo	Harmony Labs, Inc./River’s Edge Pharmaceuticals, LLC	III	Product lacks stability: no documentation of stability for 2006 and 2007.
Fluocinonide Ointment USP	Nycomed US, Inc.	III	Out-of specification result for a known degradant was obtained for a previous batch of Fluocinonide Ointment USP, 0.05%. The firm is recalling the three batches as a precaution.
RE Pramoxine-HC (hydrocortisone/chloroxylenol/pramoxine HCl)	Sonar Products, Inc./River’s Edge Pharmaceuticals, LLC	III	Product lacks stability.
Risperidone Tablets USP, 2 mg and 4 mg	Dr Reddy's Laboratories	III	Impurities/Degradation Products: Out of Specification results for impurities at the 18 month time point.
Six products*	Harmony Labs, Inc./River's Edge Pharmaceuticals, LLC	III	Product lacks stability: documents indicated potential problems with assay.
* Benzoyl Peroxide Cleanser, Topical Acne Therapy, 4.5%, 400 mL bottle; Benzoyl Peroxide Cream, Topical Acne Therapy, 6.5%, 125 mL tube; Benzoyl Peroxide Gel, Topical Acne Therapy, 4.5%, 125 mL tube; Benzoyl Peroxide Pad, 4.5%, box containing 30 foil pouches each with a single-use medicated pad (6 mL each); Benzoyl Peroxide Cleanser, Topical Acne Therapy, 6.5%, 400 mL bottle; Benzoyl Peroxide Cleanser, Topical Acne Therapy, 8.5%, 400 mL bottle
Gemfibrozil tablets, USP, 600 mg	Sun Pharmaceutical Industries Inc.	III	Impurities/Degradation Products: This product is being recalled because of Out of Specification results for the largest unspecified impurity at the 9-month stability test point.
Hydrocortisone and Acetic Acid Otic Solution, some of it branded as Acetasol HC	Actavis Mid Atlantic LLC	III	Impurities/Degradation Products: Out-of-specification (OOS) stability results for hydrocortisone related compounds.
Pancuronium Bromide Injection, 2 ml vials, 5 ml multidose vials and 10 ml multidose vials	Teva Parenteral Medicines Inc./Teva Pharmaceuticals USA, Inc.	III	Impurities/degradation products. These products are being recalled because they do not meet specification for related substances.
Semprex-D capsules (8 mg acrivastine/60 mg pseudoephedrine hydrochloride)	DSM Pharmaceuticals Inc./UCB Manufacturing, Inc.	III	Impurities/Degradation products.
Lorazepam tablets	Sandoz, Inc.	III	Impurities/degradation products: The product exceeds the Related Compound C degradant specification prior to expiry.
Quixin (levofloxacin) 0.5% sterile topical ophthalmic solution	Santen Oy / Santen Inc.	III	Impurities/degradation products. Out of specification levofloxacin-N-oxide (NOXO), a degradant of levofloxacin, stability test results was 0.59% at the 36 months stability (Specification limit is 0.5%).
Heparin sodium, USP (API) powder	Pfizer Inc.	III	Impurities/degradation products. Heparin Sodium, USP lot 80405A is outside the endotoxin specification of not more than 0.03 EU/U.
Acuvail (Ketorolac tromethamine) 0.45% ophthalmic solution	Allergan Sales LLC/Allergan Inc.	III	Failed pH specifications. Some lots found to be pH out of specification.
Sani Pads	G & W Laboratories, Inc.	III	Product lacks stability. The 18 month room temperature stability alcohol assay value failed to meet specifications.
MiraLAX (polyethylene glycol 3350) powder for solution	Schering Corp.	III	Defective Container: products may contain defective (burnt) cap liners and the product may have an off odor and off taste.
Loratadine orally disintegrating tablets	Watson Laboratories Inc./L. Perrigo Co.	III	Stability data does not support expiration date: product failed stability test results at the 6-month time point.
Colace (docusate sodium) liquid 1% stool softener	Wellspring Pharmaceutical Canada /P F Laboratories Inc.	III	Impurities/Degradation Products: OOS result for benzophenone during testing at the manufacturer.
Oxybutynin chloride oral solution USP	Apotex Inc. / Apotex Corp.	III	Does not meet the current specification for appearance. Concentration of the colorant in the batch is in excess of that identified in the formulation.
Dermisa benzoyl peroxide with aloe vera cream	Sheffield Pharmaceuticals Div. of Faria Limited LLC	III	Lacks stability. Separation of the matrix and the loss of homogeneity.
Hydrocortisone valerate ointment USP	Taro Pharmaceuticals Inc./Taro Pharmaceuticals U.S.A.	III	Crystallization. Out-of-specification for homogeneity crystal size.
Contamination/Sterility Assurance
Hyaluronidase PF 150 units/ml, 160 units/ml and 1,500 units/ml	AnazaoHealth Corp.	I	Product is being recalled due to reports of adverse events such as lid swelling, periorbital cellulitis and chemosis.
NeoProfen (ibuprofen lysine) injection	Ben Venue Laboratories Inc./Lundbeck Inc.	I	Visible particulate matter observed in two NeoProfen lots
Metronidazole injection; ciprofloxacin in dextrose (5%) injection, 200 mg and 400 mg strengths; and Ondansetron in 5% dextrose injection	Claris LifeSciences Ltd./Claris LifeSciences Inc.	I	Lack of assurance of sterility. The intravenous medication ciprofloxacin is being recalled for lack of assurance of sterility because it may be contaminated with mold, fungus and/or bacteria.
Metronidazole injection, USP	Claris Lifesciences Ltd./Pfizer Inc.	I	The intravenous medication metronidazole was found to be contaminated with mold, fungus and/or bacteria.
Metronidazole injection	Claris LifeSciences Ltd./Sagent Pharmaceuticals Inc.	I	Non-Sterility: This product is being recalled because of two complaints of a white feathery substance floating inside the IV bag which was identified as Mucor spp. fungus.
Ondansetron in 5% dextrose injection	Claris LifeSciences Ltd./Sagent Pharmaceuticals Inc.	I	Non-Sterility: This product is being recalled because a white feathery substance found floating inside the IV bag was identified as mold.
Methotrexate injection USP 2 ml and 10 ml single-dose vials	Ebewe Pharma Ges MBH Nfg KG/Sandoz Inc.	I	Presence of Particulate Matter: Injectable drug product may contain glass flakes
Five intravenous fat emulsion products*	Hospira Inc.	I	Presence of Particulate Matter: The may contain stainless steel particulate matter.
* Liposyn III 10%, 20% and 30%, and Liposyn II 10% and 20%
Six products*	Hospira, Inc.	I	Presence of Particulate Matter: Particle substance observed in the bottom of filled product retains samples.
* Propofol Injectable Emulsion 1%; Liposyn II Intravenous Fat Emulsion 10%; Liposyn II Intravenous Fat Emulsion 20%; Liposyn III Intravenous Fat Emulsion 10%; Liposyn III Intravenous Fat Emulsion 20%; Liposyn III Intravenous Fat Emulsion 30%
Megatope (iodinated I-131 albumin injection USP) solution	Iso-Tex Diagnostics, Inc.	I	Non-Sterility.
Ketorolac Tromethamine Injection 30 mg/ml single-dose vials, 15 mg/ml single dose vials and 60 mg/2 ml single dose vials	Luitpold Pharmaceuticals, Inc.	I	Presence of Particulate Matter: Firm observed particles in some retain vials of Ketorolac Tromethamine Injection, USP, 30 mg/mL & 15mg/mL.
Nzu (natural) clay substance	Martana Nigeria Ltd /Tropical Foods Warehouse	I	Chemical Contamination: This is sold in ethnic stores and is intended to treat, cure or mitigate morning sickness in pregnant women. FDA analyses found it to contain high levels of lead and arsenic.
Vicks Sinex Vapo Spray (Oxymetazoline HCl) Nasal Spray	Procter & Gamble	I	Microbial Contamination of Non-Sterile Product: Product may be contaminated with bacteria Burkholderia cepacia. A stability sample had failed microbial content testing. The microbial content was 8560 cfu/ml for total aerobic count (specification maximum is <100 cfu/ml).
Seven Procrit (epoetin alfa) injection products: 1 ml single-use vials with 2,000, 3,000, 4,000, 10,000, 20,000 and 40,000 units/ml, and 2 ml single-use vials with 10,000 units/ml	Amgen Manufacturing /Centocor Ortho Biotech Inc.	II	Presence of Particulate Matter: Extremely thin glass flakes (lamellae) have the potential to be present in Procrit (epoetin alfa) vials.
Epogen (epoetin alfa) recombinant injection, 2,000, 3,000, 4,000. 10,000 and 20,000 units/ml in 1 ml vials and 10,000 units/ml in 2 ml vials	Amgen Manufacturing Ltd. / Amgen Inc.	II	Presence of particulate matter. The firm is conducting a voluntary recall of the lots of Epogen (epoetin alfa) due to the presence of glass flakes that are extremely difficult to see, discovered in a number of vials.
Procrit (epoetin alfa) injection, 2,000 units/1ml vial, 20,000 units/2 ml vial, 20,000 units/1 ml vial and 40,000 units/1 ml vial	Amgen Manufacturing Ltd/Centocor Ortho Biotech Inc.	II	Presence of particulate matter. This is an extension of the Presence of Particulate Matter: This is an extension of the Procrit recall initiated on September 22, 2010, due to extremely thin glass flakes that have the potential to be present in Procrit (epoetin alfa) vials.
Enbrel (etanercept) SureClick Autoinjector	Amgen Manufacturing, Ltd.	II	Lack of Assurance of Sterility: Syringe barrel flange that slightly deviated from the center line of the syringe barrel, resulted in broken or cracked syringes.
Ipratropium Bromide Nasal Solution, 0.03% and 0.06%, and Fluticasone Propionate USP Nasal Spray	Apotex Corp.	II	Presence of Foreign Substance(s): Product is being recalled due to possible contamination with metal fragments.
Heparin sodium injection USP	APP Pharmaceuticals, LLC, and Actavis Totowa, LLC / American Health Packaging	II	Lack of assurance of sterility. Due to a CGMP deviation at the manufacturing firm. American Health Packaging is conducting a sub-recall in response to the manufacturing firm's recall.
Sertraline HCl tablets	Aurobindo Pharma Limited	II	Adulterated Presence of Foreign Tablets: One foreign tablet of Zolpidem Tartrate Tablets, 10 mg, was found in a bottle of 100 count Sertraline HCL Tablets, 100 mg.
Heparin sodium in 5% dextrose injection; Heparin sodium in 0.9% sodium chloride injection	B. Braun Medical Inc.	II	Presence of Foreign Substance: single API lot indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant.
Temodar (Temozolomide) for Injection	Baxter Oncology GmbH/Schering Corp.	II	There is potential for defects to exist in the glass vials that may, in rare cases, result in damage to the vials that may compromise the integrity of the vials. Use of these vials which are damaged may present a risk of infection to patients, particularly those who are immunocompromised.
Hylenex recombinant (Hyaluronidase human) injection	Baxter Pharmaceuticals Solutions	II	Presence of Foreign Substance: The affected lots were found to contain small, flake-like glass particles.
BiCNU (Carmustine) for Injection	Ben Venue Laboratories Inc./Bristol-Myers Squibb Co.	II	Lack of Assurance of Sterility: Lack of assurance of sterility of one lot of carmustine during retesting after importation through the European Union, to Argentina.
Rifampin USP, lyophilized powder for injection	Ben Venue Labs Inc.	II	Lack of assurance of sterility: Non-viable particulate (NVP) monitoring results exceeded action limits for approximately 40% of the filling operation which was not detected or corrected during the fill.
Alcohol-free hand sanitizer foam	Best Sanitizers Inc./Best Sanitizers Inc.	II	Product may be contaminated with Burkholderia cepacia.
Instant hand sanitizer	Canberra Corp.	II	Microbial contamination of non-sterile products. FDA testing results identified gram negative bacteria Pseudomonas Putida.
Ciprofloxacin in dextrose (5%) injection, 100 ml and 200 ml doses, and Ondansetron in 5% dextrose injection	Claris Lifesciences Ltd./Pfizer Inc.	II	Lack of Assurance of Sterility: The intravenous medication ondansetron is being recalled for lack of assurance of sterility because it may be contaminated with mold, fungus, and/or bacteria.
Metronidazole injection USP and Ondansetron in 5% dextrose injection	Claris Lifesciences Ltd./West-ward Pharmaceutical Corp.	II	Lack of assurance of sterility. The intravenous medications metronidazole and ondansetron were manufactured for West-Ward by the same firm which manufactured the same products for another distributor which was found to be contaminated with mold, fungus or bacteria.
GlipiZIDE and Metformin HCL tablets: 2.5 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg	Corepharma LLC	II	Tablets have the potential to contain metal particulates.
Glyburide (Micronized) and Metformin HCl tablets: 1.25 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg	Corepharma LLC	II	Tablets have the potential to contain metal particulates.
Propofol injectable emulsion 1%	Hospira Inc.	II	Presence of Particulate Matter: The may contain stainless steel particulate matter.
Midazolam injection USP	Hospira Inc.	II	Lack of Assurance of Sterility: Quality procedures were incomplete prior to the release of the product which could result in cracked vials which could compromise the sterility of the product.
Fosphenytoin sodium injection USP	Hospira Inc.	II	Presence of particulate matter. Exceeds the limit of particulate matter allowed by USP.
Cleviprex (clevidipine butyrate) injectable emulsion (0.5 mg/mL); 25 mg/50 mL single use vials	Hospira, Inc./The Medicines Company	II	Presence of particulate matter: Visible particulate matter was observed in certain lots of Cleviprex 0.5 mg/mL.
Cleviprex (Clevidipine Butyrate) Injectable Emulsion (0.5 mg/mL)	Hospira, Inc./The Medicines Company	II	Presence of Particulate Matter: The firm is expanding the recall of Cleviprex to include four additional lots due to the potential presence of stainless steel particulates.
Epinephrine injection USP in Twinject and two other dosage configurations	Hospira, Inc.; Covidien LP; Phillips Plastics Corp., Phillips Medical/Shionogi Pharma Inc.	II	Lack of assurance of sterility. Possibility exists a small number of sheaths covering the needle may have pinholes.
Fisiolin (sodium chloride) sterile nasal drops	Laboratorios L.O. Oftalmi/Oftalmi Corp.	II	Lack of Assurance of Sterility: Products were manufactured in conditions that compromised the sterility of the products.
Four ophthalmic products*	Laboratorios L.O. Oftalmi/Oftalmi Corp.	II	Lack of Assurance of Sterility: Products were manufactured in conditions that compromised the sterility of the products.
* Camolyn, Homeopathic (Matricaria chamomilla tincture HPUS 3X, Hamamelis virginiana tincture HPUS 3X) eye drops; Camolyn-A (Naphazoline hydrochloride 0.025%, Pheniramine Maleate 0.3%) eye drops; Camolyn Plus (Naphazoline Hydrochloride 0.012%, Matricaria Chamomile 0.2%, Virginian Hamamelis 0.1%) eye drops; Camolyn Refresh (Dextran 70%, Hydroxypropyl Methylcellulose 0.3%) eye drops
Magnesium sulfate injection, USP	Luitpold Pharmaceuticals Inc.	II	Some vials of this lot were observed to be slightly discolored and, upon standing, have the appearance of sediment on the bottom of the vials. Subsequent independent laboratory testing found the presence of fine iron particles.
Benadryl Allergy (Diphenhydramine HCl/Antihistamine) Tablets	McNeil Consumer Healthcare	II	Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
Simply Sleep Nightime Sleep Aid Contains Diphenhydramine HCl Caplets	McNeil Consumer Healthcare	II	Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2, 4, 6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
St. Joseph Safety Coated Aspirin (Aspirin) Enteric Coated Tablet	McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.	II	Chemical contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
Tylenol Arthritis Pain, (acetaminophen), Extended-Release Caplets	McNeil Consumer and Specialty Pharmaceuticals/McNeil Consumer Healthcare	II	Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2, 4, 6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
Tylenol 8 HR extended release caplets (acetaminophen)	McNeil Consumer Healthcare, Div Of McNeil-PPC, Inc.	II	Chemical contamination. Presence of a chemical called 2,4,6,-tribromoanisole.
Five Motrin products*	McNeil Healthcare LLC/McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.	II	Chemical contamination. The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
* Motrin IB (Ibuprofen) tablets USP 200mg; Motrin IB (Ibuprofen) tablets USP 200mg Coated Caplets; Motrin Junior Strength for ages 6-11 (Ibuprofen), Grape Flavored Chewable Tablets, 100mg; Motrin Junior Strength for ages 6-11 (Ibuprofen) Easy-to-Swallow Caplets; Motrin Junior Strength for ages 6-11 (Ibuprofen) Orange Flavored Chewable Tablets
Seventeen Tylenol Brand Products*	McNeil Healthcare, LLC/McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.	II	Chemical Contamination; presence of a chemical called 2,4,6-tribromoanisole.
* Tylenol Extra Strength Caplets (acetaminophen) 500 mg; Tylenol Extra Strength Cool Caplets, (acetaminophen), 500 mg; Tylenol Extra Strength EZ Tabs, (acetaminophen), 500 mg; Tylenol Extra Strength Rapid Release Gels (acetaminophen) 500 mg; Tylenol Extra Strength Tablets, (acetaminophen), 500 mg each, Crushable, Dye Free; Tylenol Caplets (acetaminophen), 325 mg, 50-count bottle; Tylenol Regular Strength Tablets (acetaminophen), 325 mg, 100-count bottle; Tylenol 8HR Extended Release Caplets, (acetaminophen), 650 mg each, capsule-shaped bi-layer tablets; Tylenol 8 Hour Extended Release Caplets, (acetaminophen), 650 mg each; Tylenol Arthritis Pain Extended Release Caplets, (acetaminophen), 650 mg each; Tylenol PM Extra Strength Caplets (acetaminophen 500 mg and diphenhydramine HCl 25 mg); Tylenol PM Extra Strength Geltabs, (acetaminophen 500 mg and diphenhydramine HCl 25 mg); Tylenol PM Extra Strength Rapid Release Gelcaps (acetaminophen 500 mg and diphenhydramine HCl 25 mg); Children's Tylenol Meltaways, (acetaminophen) 80 mg, Bubblegum Burst flavor; Children's Tylenol Meltaways, (acetaminophen), 80 mg, Grape flavor; Tylenol Day & Night Value Pack contains Tylenol Extra Strength Caplets (acetaminophen 500 mg) 50 count bottle and Tylenol PM Caplets (acetaminophen 500 mg and diphenhydramine HCl 25 mg) 24 count bottle; Tylenol Arthritis Pain Extended Release Geltabs, (acetaminophen), 650 mg
10 products*	McNeil Healthcare, LLC/McNeil Consumer Healthcare, Div Of McNeil-PPC, Inc.	II	Chemical contamination. Presence of a chemical called 2,4,6-tribromoanisole (TBA) in products.
* Motrin IB (Ibuprofen) Tablets; Motrin IB (Ibuprofen) Caplets; Benadryl (Diphenhydramine HCl) Allergy tablets; Tylenol (Acetaminophen) Tablets; Tylenol (Acetaminophen) Capsules; Tylenol PM (Acetaminophen/Diphenhydramine HCl) Caplets; Tylenol PM (Acetaminophen/Diphenhydramine HCl) Geltab; Tylenol PM (Acetaminophen/Diphenhydramine HCl) Gelcaps
Benadryl (Diphenhydramine HCl) Allergy Ultratabs	McNeil Healthcare, LLC/McNeil Consumer Products Co.	II	Chemical contamination: presence of a chemical called 2,4,6,-tribromoanisole (TBA).
Four Rolaids products*	McNeil Healthcare/McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.	II	Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
* Extra Strength Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) FRESGMINT Tablets, Original Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Peppermint Tablets, Extra Strength Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Fruit Tablets, Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Cherry Tablets, Rolaids MULTI-SYMPTOM Antiacid & Antigas (Calcium Carbonate, Magnesium Hydroxide & Simethicone) Berry Tablets, Extra Strength Rolaids Antiacid (Calcium Carbonate & Magnesium Hydroxide) Tropical Punch Tablets,
Cancidas (caspofungin acetate) for injection	Merck & Co. Inc./Merck Sharp & Dohme	II	Lack of assurance of sterility (cracked vials).
Spectrum Kanamycin Sulfate, USP	North China Pharm./Spectrum Chemicals and Laboratory Products	II	Presence of foreign substance; trimethoprim detected.
Four products*	Nycomed U.S., Inc.	II	Lack of Assurance of Sterility. Potential bacterial contamination.
* Erythromycin Ophthalmic Ointment USP; Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP; Gentamicin Sulfate Ophthalmic Ointment USP; Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP
Puralube Ointment (Petrolatum Ophthalmic Ointment), Sterile Ocular Lubricant, Net Wt 1 gram, tube, OTC	Nycomed U.S., Inc.	II	Lack of Assurance of Sterility. Potential bacterial contamination.
Lorazepam tablets USP	Ohm Laboratories Inc./Ranbaxy Pharmaceuticals Inc.	II	Adulterated presence of foreign tablets. A foreign tablet was discovered during the dispensing/counting of the medication.
Glumetza metformin HCl extended release tablets	Patheon Puerto Rico Inc./Depomed Inc.	II	Chemical contamination; TBA (2,4,6 tribomoanisole).
Lipitor (atorvastatin calcium) tablets	Pfizer Ireland Pharmaceuticals; Pfizer Manufacturing Deutschland Gmbh; Rexam, Las Piedras Puerto Rico./Pfizer Inc.	II	Chemical contamination. Complaints of an uncharacteristic odor identified as 2, 4, 6 tribromoanisole.
Lipitor (atorvastatin calcium) tablets	Pfizer Ireland Pharmaceuticals; Pfizer Manufacturing Deutschland GmbH; Rexam/Pfizer Inc. / Pfizer Inc.	II	Chemical contamination. Firm received complaints of an uncharacteristic odor which was subsequently attributed to contamination by 2,4,6 tribromoanisole.
Velcade (bortezomib) for injection	Pierre Fabre Medicament Production/Millennium Pharmaceuticals Inc.	II	Presence of particulate matter. The firm is recalling Velcade because of the potential for the presence of visible particulates identified as polyethylene terephthalate polyester (PET) which could be present and in the reconstituted injectable drug.
MD Quality Hand Sanitizer, Gel, 0.13% Benzalkonium Chloride	Puerto Rico Beverage Inc./Morales Distributors, Inc.	II	Microbial contamination of Non-Sterile products. FDA samples showed contamination with Burkholderia cepacia (a.k.a. Pseudomonas cepacia).
Firmagon (Degarelix) for Injection 80 mg and 240 mg	Rentschler Biotechnologie Gmbh & Co. KG/Ferring Pharmaceuticals Inc.	II	Lack of Assurance of Sterility: A small number of defective containers (reject vials) were introduced into commercial distribution.
Estradiol valerate injection USP, 20 mg/ml and 40 mg/ml 5 ml multidose vials	Sandoz Canada Inc./Sandoz Inc.	II	Presence of Particulate Matter: Product was out of specification for particulate matter.
Apidra SoloStar insulin glulisine (rDNA origin) injection	Sanofi Aventis Deutschland GmbH/Sanofi-Aventis	II	Lack of Assurance of Sterility.
Sterile-Eyes, eye wash (purified water) first aid treatment	Stericon Pharma Pvt. Ltd./Genuine First Aid	II	The product manufacturer was recently cited for significant violations of Current Good Manufacturing Practices (CGMP) regulations for Finished Pharmaceuticals. The firm cannot assure sterility of their finished sterile products.
Steril-Eyes (purified water) eye wash	Stericon Pharma Pvt. Ltd./Water-Jel Technologies, LLC	II	cGMP deviations. For significant violations of Current Good Manufacturing Practices (CGMP) regulations for Finished Pharmaceuticals, the firm cannot assure sterility of their finished sterile products.
Bumetanide injection USP 2 ml, 4 ml and 10 ml vials	Teva Parenteral Medicines Inc./ Teva Pharmaceuticals USA Inc.	II	Presence of particulate matter. Particulate matter was found in lots of retain samples.
Sulfamethoxazole and Trimethoprim Injection	Teva Pharmaceuticals USA, Inc.	II	Lack of Assurance of Sterility: Defective/loose crimps.
Little Tummys Stimulant Laxative Drops	Altaire Pharmaceuticals, Inc./Medtech Products, Inc.	III	Defective Container: seal breach on tamper evident foil seal.
Cleocin Phosphate IV (clindamycin) injection, 300 mg, 600 mg and 900 mg per 50 ml	Baxter Healthcare Corp./Pfizer Inc.	III	Presence of foreign substance(s). The active pharmaceutical ingredient (API) used in the affected lots may have been contaminated with paraffin wax.
Clindamycin injection USP	Ben Venue Laboratories Inc.	III	Presence of foreign substance(s). Trace quantities of n-paraffin were found in the Clindamycin Phosphate Active Pharmaceutical Ingredient (API) by the API manufacturer.
Anastrozole tablets	Fresensius Kabi Oncology Ltd./APP Pharmaceuticals LLC	III	Cross contamination w/other products. A potential for some foreign tablets to be in bottles of anastrozole tablets 1 mg.
Sea Pure 100% Natural Sheer Lotion SPF 15	H2O Plus, L.P.	III	Error with Regard to Preservative: The lotion has the potential for preservative failure, which would allow mold growth to occur.
Fluocinonide Cream	Nycomed US Inc.	III	Firm received one complaint of leakage from tube crimp.
Loratadine oral solution	Silarx Pharmaceuticals Inc.	III	Presence of particulate matter. The manufacturer received one complaint of minute particulate in Loratadine Oral Solution, Control # 5890. The firm has decided to recall a total of 10 lots as a precaution.
Effexor XR (Venlafaxine HCl) extended release capsules, 37.5 mg, 75 mg and 150 mg	Wyeth Pharmaceuticals Co.	III	Cross contamination with other products. Firm is recalling Effexor extended release lots because of a potential cross-contamination issue at one of their API suppliers.
Effexor (Venlafaxine hydrochloride) extended release capsules	Zach Systems/Wyeth Pharmaceuticals Co.	III	Cross Contamination With Other Products: Firm is recalling Effexor extended release lots because of a potential cross-contamination issue at one of their API suppliers.
Tropical Breeze (Triclosan) antibacterial foaming soap	Zep Manufacturer	III	The product will not meet its normal shelf life of two years due to the presence of spoilage organisms.
Labeling/Packaging Mix
Arrow Brand Medicated Oil & Embrocation	Da Chon Hua Trading /J J J Distributors	I	Labeling: Label Lacks Warning or Rx Legend: FDA issued a warning to consumers not to purchase the product due to flawed labeling which may mislead consumers to ingest product orally. The product contains ingredients that may be toxic if ingested.
Humira (Adalimumab) Pen	Abbott Laboratories	II	Unit dose mispackaging. Some of the Humira Psoriasis Starter Packages may have been assembled in a configuration in which the positions of the pens within the Starter Package carton were inconsistent with the intended positions correlating to the recommended initial dosing regimen.
Alka-Seltzer Plus Day & Night Cold Formulas Liquid Gels	Accucaps Industries Limited/Bayer Healthcare	II	Label mix-up. Firm is recalling one lot of Alka Seltzer Plus Day & Night Cold Formulas Liquid Gels (combination pack only) after identifying that the label on the foil blister card of certain packages were printed with the label reversed. Therefore, the label for the green Night product appears under some of the blue Day product and vice versa.
Sensorcaine injection solution 0.5% bupivacaine HCl and epinephrine injection, USP	AstraZeneca LP /APP Pharmaceuticals LLC	II	Some of the vial labels are missing red text that should state "with Epinephrine 1:200,000 (as bitartrate" and "Warning: Contains Sulfites".
Ixempra Kit (ixabepilone) for Injection	Baxter Oncology GmbH /Bristol-Myers Squibb Company	II	Label Mix-Up: IXEMPRA vial within kits with lot number 8K017C is labeled as "Diluent for IXEMPRA for injection 8mL."
Butorphanol tartrate injection USP	Ben Venue Laboratories Inc.	II	Labeling. Label w/wrong or Incorrect Exp Date: The expiration date on the labeling is incorrect; labeled with an expiration date of JUL 2012 instead of JUL 2011.
APS Coumadin (warfarin sodium tablets, USP)	Bristol-Myers Squibb Holdings Pharma Ltd./American Health Packaging	II	This sub-recall was initiated to comply with Bristol-Myers Squibb recall (dated June 25, 2010) that was determined that some tablets, over time, may not meet specifications for isopropanol, which is required to maintain the active ingredient in a crystalline state.
Milk of Magnesia (Magnesium Hydroxide)	L. Perrigo Co.	II	Labeling: Label mix-up; Product is labeled as sugar-free but it actually contains sugar.
Milk of Magnesia (Magnesium Hydroxide)	L. Perrigo Co.	II	Labeling: Label mix-up: Product is labeled as sugar-free but it actually contains sugar.
Dopamine HCl injection USP	Luitpold Pharmaceuticals Inc.	II	Labeling. The label lacks warning or Rx legend. The vial label was missing the red printing "DOP" and "WARNING: NOT FOR DIRECT IV INJECTION. MUST BE DILUTED BEFORE USE. IV INFUSION ONLY." statement.
Losartan potassium and hydrochorothiazide tablets	Merck Sharp & Dohme Ltd. / Merck and Co., Inc.	II	Labeling error: The front portion of the bottle label correctly states the product strength as "100mg/12.5mg", while the text on the back portion of the bottle label incorrectly states "Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide."
Diovan HCT (valsartan and hydrochlorothiazide) tablets, USP, 320 mg/25 mg	Novartis Pharmaceuticals Corp.	II	Labeling: Incorrect Lot No(s): One of the two NDC numbers on the unit-dose blister-card is incorrectly printed as 0078-0471-15, which corresponds to Diovan HCT 320mg/12.5mg Tablets.
Diovan HCT valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corp.	II	Labeling mix-up. The firm received complaints that bottles labeled to contain Diovan HCT 320/12.5mg tablets actually contained Diovan HCT 320/25mg.
Four oral saline laxative products containing dibasic and monobasic sodium phosphate that are unflavored or ginger lemon, cherry or lemon flavored	Perrigo Florida Inc.	II	Label mix-up. The product label insert mentions one of the uses as bowel cleansing, but products are not recommended for bowel cleansing.
MethylPREDNISolone Acetate Injectable Suspension, 40 mg/ml and 80 mg/ml, in cases of 96 or 120 single-dose vials	Sandoz, Inc.	II	Methylprednisolone Acetate in the 40 and 80 mg, single dose lots were mistakenly labeled with a 24 month expiration date instead of 18 months.
Premier Value Cold Head Congestion	AAA Pharmaceutical Inc.	III	The active ingredient, guaifenesin, is incorrectly listed on the principal display panel.
Sulfamethoxazole and trimethoprim DS tablets USP	Amneal Pharmaceuticals of New York/Blenheim Pharmacal Inc.	III	The repacked lot was labeled with an extended expiration date in error.
Paroxetine tablets	Aurobindo Pharma Limited/Aurobindo Pharma USA	III	Label mix-up. Some bottles labeled as Paroxetine 40 mg tablets actually contain Citalopram 20 mg tablets.
D-17 Tumorell Homeopathic Formula; D-24 Pneumell Homeopathic Formula; D-33 Spasmonell, Homeopathic Formula; D-40 Peranemiol Homeopathic Formula; D-46 Goutinol Homeopathic Formula; D-48 Pulmonon Homeopathic Formula; D-62 Rubilin Homeopathic Formula	Dynamic Nutritional Associates	III	Unapproved Drug; products labeled as over the counter homeopathic drugs, however are labeled with drug claims.
Wellbutrin SR (bupropion HCl) sustained-release tablets	GlaxoSmithKline Inc.	III	Labeling. Label with Wrong or Incorrect Expiration Date; Bottles designated as sub-lot E on the bottle label were incorrectly imprinted with the expiry year transposed as 2102 (instead of 2012).
Oxcarbazepine tablets, 150 mg and 300 mg	Glenmark Generics Ltd./Glenmark Pharmaceuticals Inc.	III	Incorrect or missing package insert. A typographical error was found in the "How Supplied" section of the package outsert, showing the wrong imprint description for 150mg, 300mg and 600mg tabs.
Zoderm (6.5% benzoyl peroxide) cleanser	Groupe Parima Inc./Nycomed US, Inc.	III	Labeling. Correct Labeled Miscart/Mispack: the firm received a customer complaint that two of twelve cartons received were labeled as Zoderm Cleanser 4.5% but they actually contained bottles of Zoderm Cleanser 6.5%.
Amlodipine Besylate Tablets	InvaGen Pharmaceuticals, Inc.	III	Incorrect or missing package insert.
Milk of Magnesia Mint Flavor and Original Saline Laxatives	L. Perrigo Co.	III	Misbranded; the amount of calcium and magnesium per tablespoon are understated in the "Other information" box on the Drug Facts statement (magnesium content is listed as 160mg/15ml when it should be listed as of 520mg/15ml; the calcium content is listed as 5mg/15ml instead of 20mg/15ml).
Milk of Magnesia Mint Flavor saline laxative packed in 12 oz and 26 oz bottles; Milk of Magnesia Original saline laxative in 12 oz bottles	L. Perrigo Co.	III	Misbranded; the amount of calcium and magnesium per tablespoon are understated in the "Other information" box on the Drug Facts statement (magnesium content is listed as 160mg/15mL when it should be listed as of 520mg/15ml; the calcium content is listed as 5mg/15ml instead of 20mg/15mL).
Acetaminophen tablets	L. Perrigo Co.	III	The liver warning section of the product label warns that severe liver damage may occur if an adult takes more than 8 tablets in 24 hours. The warning should state that liver damage may occur if an adult takes more than 12 tablets in 24 hours.
Acetaminophen tablets	L. Perrigo Co.	III	The liver warning section of the product label warns that severe liver damage may occur if an adult takes more than 8 tablets in 24 hours. The warning should state that liver damage may occur if an adult takes more than 12 tablets in 24 hours.
Stomach Relief bismuth subsalicylate chewable tablets	L. Perrigo Co.	III	Label lacks warning. The label does not include the required calcium content warning statements.
Our Family Ibuprofen Caplets	LNK International, Inc.	III	Mislabeling. The directions on the outer box are wrong and lack the word "not", thereby incorrectly reading "Do exceed 6 caplets in 24 hours unless directed by a doctor".
Seven products*	McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.	III	Incorrect/missing lot numbers. There is a potential for the product lot number and/or expiration date to become illegible on the bottle label.
* Concentrated Tylenol Infants' Drops, (Acetaminophen), 80 mg, Grape Flavor; Concentrated Tylenol Infants' Drops (Acetaminophen), 80 mg, Dye Free, Cherry Flavor; Concentrated Tylenol Infants' Drops(Acetaminophen), 80 mg, Cherry Flavor; Concentrated Motrin Infants' Drops (Ibuprofen), 50 mg, Dye-Free, Original Berry Flavor; Concentrated Motrin Infants' Drops, (Ibuprofen), 50 mg, Original Berry Flavor; Children's Zyrtec Allergy, (Cetirizine HCl) Allergy, 1 mg, Syrup, Bubble Gum; Johnson's Baby Relief Kit, OTC, which contains Concentrated Tylenol Infants Drops, Grape, and Concentrated Motrin Infants Drops, Berry
Tretinoin cream	Ortho Pharmaceutical Division of Janssen Ortho LLC /L. Perrigo Co.	III	Label error on declared strength. Tretinoin Cream 0.025% was packaged in tubes labeled as Tretinoin Cream 0.1%.
Clearasil Ultra (2% Salicylic Acid) Overnight Wash; Clearasil Ultra (2% Salicylic Acid) Acne Clearing Gel Wash	Reckitt Benckiser	III	Product has potential for losing lot code information when unwrapped.
The Original Mane & Tail Anti-dandruff Shampoo	Straight Arrow Products Inc.	III	A formula improvement was made and a determination through audit revealed that in the transition to a new label the ingredient statement was incomplete.
Sulfacetamide sodium topical suspension	Taro Pharmaceuticals Inc. / Taro Pharmaceuticals USA, Inc.	III	Label with wrong or incorrect exp. date. The product is mislabeled with an incorrect (extended) expiration period of 24 months.
Compliance With NDA/Monograph Requirements
Twenty nine brands of dietary supplement capsules containing proprietary blends of white willow bark, horny goat weed and other herbals	Atlas Operations	I	Marketed without an approved NDA/ANDA: Atlas Operations is recalling 29 products sold as dietary supplements because FDA laboratory analysis revealed the presence of an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making these products an unapproved new drugs.
Off Cycle II Hardcore capsules dietary supplement	Atlas Operations Inc./Fizogen Precision Technologies Inc.	I	Marketed without an approved NDA/ANDA; product contains "ATD" an Aromatase Inhibitor marketed as a dietary supplement.
Rock Hard Weekend capsules	Atlas Operations, Inc./Rock Hard Laboratories	I	Marketed without an approved NDA/ANDA: The product is an unapproved new drug because the product contains sulfoaildenfil.
62 dietary supplement capsule products*	Bodybuilding.com	I	Marketed Without an Approved NDA/ANDA: 62 products marketed as dietary supplements have been found to contain steroid or steroid-like substances, making them unapproved new drugs.
* D-DROL capsules, DIENE DRONE capsules, Liquid drone UTT anabolic suspension, HYPERDROL X2 capsules, MASTAVOL capsules, REVAMP capsules, ULTRA MASS STACK capsules, ULTRA RIPPED STACK capsules, Finadex capsules, STRAIGHT DROL capsules, STRAIGHT PHLEXED capsules, TESTRA FLEX capsules, METHYLDROSTANOLONE tablets, EPI-TREN capsules, Magna Drol capsules, Epivol capsules, Pheravol-V capsules, M-DROL capsules, P-PLEX capsules, X-TREN capsules, EPIO-PLEX capsules, FINABOLIC 50 capsules, REVENGE capsules, MethAnstane capsules, Susto-Test Depot capsules, ON CYCLE II HARDCORE capsules, SUS500 softgels, TREN-250 softgels, T-ROID capsules, 1,4 AD BOLD 200 capsules, 17a PheraFLEX capsules, DYMETHAZINE capsules, 2a,17a Methadrol capsules, BROMODROL tablets, GROW TABS capsules, MASS TABS capsules, OXODROL PRO tablets, RIPPED TABS TR capsules, Massdrol capsules, Phera-Mass capsules, Trenadrol capsules, MONSTER CAPS capsules, Spawn capsules, D-STiANOZOL tablets, H-DROL tablets, MD1T capsules, Nutracoastal S-Drol tablets, TRENA tablets, 2a, 17a METHASTADROL capsules, TRI-METHYL X capsules, e-pol capsules, Nasty mass capsules, RAGE RV2 capsules, RAGE RV3 capsules, RAGE RV4 capsules, RAGE RV5 capsules, FINAFLEX 550-XD capsules, FINAFLEX RIPPED capsules, FORGED EXTREME MASS capsules, FORGED LEAN MASS capsules, RIPPED TABS TR tablets, IForce Dymethazine/Reversitol Combo Pack
Solo Slim; Solo Slim Extra Strength	Changsha Foreign Economic Relations and Trade Corp., and Velocity Pharma LLC /EZVille Ltd.	I	Marketed without an approved NDA/ANDA. Solo Slim dietary supplement was found to contain undeclared didesmethyl sibutramine an analogue of sibutramine based on FDA's sampling and analysis. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss.
Vialipro capsules (Prostancus HCl)	Desert Rose Manufacturing Inc.	I	Marketed without an Approved NDA/ANDA: product contains sulfoaildenafil, an analogue of Sildenafil, an active ingredient used in the treatment of erectile dysfunction.
Masxtreme capsules	Florida Supplement Corp./Natural Wellness LLC	I	Marketed Without An Approved NDA/ANDA: FDA analysis has determined the product contains undeclared amounts of aminotadalafil, an analog of tadalafil. Tadalafil is an FDA approved drug used to treat erectile dysfunction (ED), making MasXtreme an unapproved new drug.
MasXtreme Herbal Supplement for Men	Florida Supplement Corp./Natural Wellness, LLC	I	Marketed without an approved NDA/ANDA. Product contains undeclared amounts of Aildenafil, an analog of Sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED). Product also contains the drug Phentolamine, which is used to expand blood vessels to increase blood flow.
Libipower Plus Capsules	Haloteco	I	Marketed without an approved NDA/ANDA: product found to contain tadalafil which is the active ingredient of an FDA approved drug for Erectile Dysfunction (ED).
Yi Shou capsules, 400 mg and 650 mg strengths	Healthy Body Forero	I	Marketed without approved NDA/ANDA. FDA analysis found that these products contains sibutramine, the active ingredient in an FDA-approved drug indicated for use as an appetite suppressant for weight loss, making it an unapproved new drug.
Mass Tabs Capsules; Ripped Tabs TR Tablets; Dual Action Grow Tabs capsules; Bromodrol Tablets; Ripped Tabs TR Capsules	Innovative Health Products, Inc./IDS Sports	I	Marketed without an NDA/ANDA: Product contains undeclared steroids or steroid-like substances, making them unapproved new drugs.
Slim-30 Natural Herb for Weight Loss; Joyful Slim Natural Herb for Weight Loss	J & H Besta Corp.	I	Marketed without an Approved NDA/ANDA; found to contain undeclared N-desmethy lsibutramine and traces of sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss.
Magic Power Coffee	Jiangxi Jianyuan Biological Technology Co. Ltd./INZ Distributors Inc.	I	Marketed Without an Approved NDA/ANDA: analysis of Magic Power Coffee, marketed as a dietary supplement, revealed that the contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in an FDA-approved drug for Erectile Dysfunction (ED).
STUD Capsule For Men	Kanec USA, Inc.	I	Marketed Without an NDA/ANDA: product contains sildenafil, the active ingredient in an FDA approved drug used in the treatment of erectile dysfunction, making the product an unapproved new drug.
Zicam Cold Remedy Nasal Gel & Zicam Cold Remedy Gel Swabs (Zincum Gluconium 2X)	Matrixx Initiatives Inc.	I	Reports of Adverse Events: use of product has been associated with anosmia (loss of smell) which is a long-term or permanent condition.
17 dietary supplements containing drug products*	Musclemaster.com Inc.	I	Marketed Without An Approved NDA/ANDA: These products are being recalled because they are marketed as dietary supplements, but have been found to contain steroids or steroid-like substances, making them unapproved new drugs.
* Diene Drone capsules; Liquid Drone UTT anabolic suspension; M1, 4AD; 1, 4 AD (1, 4 Androstadiene-3, 17-Dione) capsules; HyperDROL X2 Capsules; Anabolic Xtreme 3-AD [3-AD Alpha-Trophic Complex; 2-Androstenol Acetate Ester; Testra Flex capsules; M-DROL capsules; P-PLEX capsules; X-TREN capsules; D-DROL capsules; D-Drol Complex 52.5 mg; Novedex XT capsules; Halodrol liquigels; 1, 4 AD BOLD 200 capsules; 2a, 17a Methadrol capsules; Dymethazine capsules; Monster Caps capsules
Prolatis (Polygonati Annum) Dietary Supplement Capsules	Novacare LLC/Prolatis	I	Marketed without an approved NDA/ANDA. Product found to contain sulfoaildenafil, an analogue of sildenafil, an active ingredient used for the treatment of male Erectile Dysfunction.
Two sexual supplement products: Ejaculoid Xxtreme and Stimuloid II capsules	Nutraloid Labs Inc.	I	Unapproved drug: the product was found to contain sulfoaildenafil, an analogue of Sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for male Erectile Dysfunction (ED).
Slimbionic Capsules; One Weight Loss Pill; SlimDemand Capsules; Botanical Weight Loss Capsules	Young You Corporation	I	Marketed Without an Approved NDA/ANDA: product contains undeclared Sibutramine.
Pai You Guo, boxes of 30 Slim Capsules and boxes of 18 pouches, each containing one tea pack	Zhejiang Camel Transworld/GMP Herbal Products, Inc.	I	Marketed without an Approved NDA/ANDA: The recall was initiated because PAI YOU GUO, a weight loss dietary supplement, sold and marketed by the firm was found to contain undeclared drug ingredients.
Three topical gels*	Bionet Esthetics Inc.	II	Marketed Without An Approved NDA/ANDA: Firm was distributing Lidocaine based products as cosmetics.
* Aloecaine Clear 4% lidocaine gel; Aloecaine 4% lidocaine 20% benzocaine gel; Laser Soothe Gel 2% lidocaine
Red Yeast Rice 0.4%	Hangzhou Boda Biological Tech Co./Pacific Rainbow International Inc.	II	Product contains an unapproved new drug, marketed without an NDA/ANDA (contains higher than naturally occurring amounts of Lovastatin).
32 oral solid products*	Shamrock Medical Solutions Group LLC /Shamrock Medical Solutions Group LLC	II	Marketed without an approved NDA/ANDA. Split tablets distributed as an unapproved new drug.
* Allopurinol; Valcyte (valganciclovir HCl); Avapro (irbesartan); Gilmepiride; Coumadin (warfarin sodium); Sotalol HCl; Amiodarone HCl; Primidone; Captopril; GlipiZIDE; Baclofen; HydrALAzine HCl; SeroQuel (quetiapine); Metoprolol tartrate; Spironolactone; Labetalol HCl; Oxybutynin chloride; Atenolol; Nadolol; Baclofen; TraZODONE HCl; Metformin HCl; Mephyton (phytonadione); Metoprolol Succinate ER; Warfarin sodium; tramadol HCl; Misoprostol; Skelaxin (metaxalone); Ciprofloxacin; Allopurinol; Coumadin (warfarin sodium); Sotalol HCl tablets and half tablets
Abilify Discmelt (aripiprazole) tablets, 10 mg and 15 mg	Bristol-Myers Squibb Co. Inc.	III	Marketed without an approved NDA/ANDA. Abilify Discmelt Orally Disintegrating Tablets 10 mg and 15 mg were packaged and released with 3 ply aluminum blister foil. The 3 ply foil is not the current NDA approved foil.
Irinotecan Hydrochloride Injection	Sandoz Inc.	III	Marketed without an approved NDA/ANDA: Data from foreign drug development center could not be substantiated.
Manufacturing/Test Methods
Four PediaCare products*	McNeil Consumer Healthcare/Blacksmith Brands, Inc.	I	GMP deficiencies at manufacturing site.
* PediaCare Children's Multi-Symptom Cold, Grape Flavor Liquid; PediaCare Children's Long-Acting Cough, Grape Flavor Liquid; PediaCare Children's Decongestant, Raspberry Flavor Liquid; PediaCare Children's Allergy & Cold, Grape Flavor Liquid
Sandimmune cyclosporine capsules USP	Apotex / American Health Packaging	II	The recall was conducted due to potential GMP violations.
Prilosec omeprazole delayed release capsules	Apotex / American Health Packaging	II	GMP deviations (by manufacturer).
27 products*	Apotex Inc.	II	CGMP Deviations: Apotex Inc., Canada, is recalling multiple pharmaceutical products for cGMP violations that may have resulted in cross contamination.
* Carbidopa and Levodopa extended-release tablets; Clonazepam tablets; CycloSPORINE capsules; Diclofenac potassium tablets; DILT-CD (Diltiazem hydrochloride) extended-release capsules; DILTZAC (Diltiazem hydrochloride) extended-release capsules; Divalproex sodium delayed-release tablets; Eplerenone tablets; Moexipril hydrochloride tablets; Omeprazole delayed-release capsules; Ondansetron hydrochloride tablets
Avalide (irbesartan hydrochlorothiazide) tablets	Bristol Myers Squibb Manufacturing Co.	II	GMP deviation. During manufacturing, the granulation time for the finished drug product was extended, which resulted in varying levels of Polymorph Form B. Polymorph Form A is the intended form. Polymorphism is the existence of different kinds/forms of crystal of the same chemical compound. In this case the extended granulation time changed Polymorph Form A to varying levels of Polymorphic Form B.
Instant hand sanitizer (ethyl alcohol 62%) topical gel	Gasco Industrial	II	cGMP Deviations. The product was manufactured while several cGMP measures were not met.
Nine pediatric oral liquid cough/cold products*	McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.	II	Defective Container: Some products have thin walled bottles defect.
* Children's Zyrtec Oral Solution; Children's Tylenol Oral Suspension; Children's Tylenol Plus Cold & Stuffy Nose; Children's Tylenol Plus Multi-Symptom Cold; Children's Tylenol Plus Flu; Children's Tylenol Plus Cold; Children's Tylenol Plus Cold & Allergy; Children's Tylenol Plus Multi-Symptom Cold
Thirty-six pediatric oral liquid cough/cold products*	McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.	II	GMP deficiencies.
* Concentrated Tylenol infants' drops, Children's Tylenol suspension, Children's Tylenol Plus suspension, Concentrated Motrin Infants' Drops, Children's Motrin suspension, Children's Zyrtec, Children's Benadryl Allergy, all in various flavors and sizes, and Johnson's Baby Relief Kit, which contains Tylenol and Motrin infant drops
Motrin Junior Strength ibuprofen tablets	McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.	II	CGMP deviations. Insufficient development during manufacturing.
Pepcid Complete (famotidine, calcium carbonate, magnesium hydroxide) tablet; Pepcid AC (famotidine) tablets	McNeil Healthcare, LLC /Johnson & Johnson Merck	II	Defective container. Small number of bottles have been punctured at the bottom edge during the packaging process.
NaFrinse fluoride mouth rinse	Medical Products Laboratories Inc.	II	CGMP Deviations: Firm did not follow SOP/GMPs during manufacturing.
Sucralfate USP, non-sterile bulk	Nanjing Pharmaceutical Factory Co./Flavine North America Inc.	II	cGMP deviations. An FDA inspection conducted September 21-25, 2009, observed numerous violations in record keeping practices that are not in accordance with the manufacturer's related SOPs and cGMP requirements, which may cause the final product to be adulterated.
Nimodipine capsules in 30- and 100-unit blister packs	Pharmaceutics International Inc./Sun Pharmaceutical Industries Inc.	II	CGMP deviations. Leaking capsules.
PegIntron (Peginterferon alfa-2b) Powder for Injection Redipen, 50 mcg, 80 mcg, 120 mcg and 150 mcg per 0.5 ml, product of Ireland	Schering Plough Ltd./Schering Corp.	II	There is potential for a low frequency defect in the glass cartridge component of the Redipen delivery system in all strengths of Peg Intro (Peginterferon alfa-2b) Powder for injection.
L-Cysteine HCl injection, 10 ml and 50 ml vials	Teva Parenteral Medicines Inc./Teva Pharmaceuticals USA	II	CGMP deviation. Absence of stability indicating methods for assay and impurities.
Eleven Rx products *	Apotex Inc./Apotex Corp.	III	CGMP deviations. Multiple products in the U.S. market had been manufactured prior to August 2009 using API and raw materials that had passed the vendor's suggested expiry.
* Benazepril HCl tablets; Citalopram HBr tablets; DILT-XR (Diltiazem HCl) extended-release capsules; Gemfibrozil tablets; Lovastatin 10 mg, 20 mg and 40 mg tablets; Nizatidine 150 mg and 300 mg capsules; and Terazosin HCl capsules
Loratadine tablets	Apotex Inc./Apotex Corp.	III	CGMP deviations. Multiple products in the U.S. market had been manufactured prior to August 2009 using API and raw materials that had passed the vendor's suggested expiry.
Colgate GEL-KAM (0.63 stannous fluoride) oral care rinse	Colgate Oral Pharmaceuticals, Inc./Colgate Palmolive U.S.	III	Container leakage. A minor container defect, which results in leaking containers.
Rosaderm Cleanser: sulfacetamide sodium and sulfur	Harmony Labs, Inc./River's Edge Pharmaceuticals, LLC	III	Manufacturing Validation: Packaging validation was conducted after product distribution.
UltraTag RBC kit for preparing Technetium 99m-labeled red blood cells	Mallinckrodt Inc.	III	CGMP Deviations: The reaction vial was not packaged in some of the clamshell containers.
Enablex (darifenacin) extended-release tablets	Novartis Pharmaceuticals Corp.	III	Mis-packaging; a pharmacist reported receiving a 30-count bottle labeled as Enablex 15 mg Tablets, Lot F0093, that contained 29 Enablex 15 mg Tablets and 1 Enablex 7.5 mg Tablet.
Simvastatin tablets, 10 mg, 20 mg, 40 mg and 80 mg strengths	OHM Laboratories Inc./Ranbaxy Pharmaceuticals Inc.	III	Incorrect product formulation. Product contains the incorrect inactive ingredient Butylated Hydroxytoluene (BHT) instead of Butylated Hydroxyanisole (BHA).
Azathioprine tablets	Sandoz Inc.	III	CGMP deviations. Failure to fully investigate dissolution failures prior to releasing product.
DVM Hand Cleanser, Foaming Hand Cleanser, 0.375% triclosan	TEVA Animal Health Inc.	III	cGMP deviation. The product was not manufactured in conformance with GMPs.